stroke
Conditions
Interventions
Experimental group1:Patients with massive cerebral infarction will be given local injection of BTX-A + low-frequency rTMS (1 Hz) on the contralateral side
Experimental group2:Patients with non-massive cerebral infarction will be given local injection of BTX-A + high-frequency rTMS (10-20 Hz) on the affected side
Experimental group3:Patients with massive/non-massive cerebral infarction will be given local injection of BTX-A
Experimental group4:Patients with massive cerebral infarction will be given low-frequency rTMS (1 Hz) on the contralateral side
Experimental group5:Patients with non-massive cerebral infarction will be given high-frequency rTMS (10-20 Hz) on the affected side
Sponsors
First Affiliated Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Unilateral limb paralysis caused by the first stroke; 2. Large area cerebral infarction; 3. Age >=18 years old; 4. According to the National Institutes of Health Neurological Impairment Score (NIHSS) scoring standard, the score is 10-20 points; 5. Within 1-6 months after the onset of stroke, there is at least one spastic muscle group on the affected side, and the lower limb muscle spasticity grade is >= 2 by the modified Ashwonh spasticity assessment; 6. The patient has the ability to walk independently (with or without walking aids); 7. Those with poor oral anticonvulsant effect or serious adverse reactions; 8. Patients and their families signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Contraindications for rTMS treatment: internal pacemaker, intracranial metal implants such as stents, history of epilepsy; 2. There are contraindications to botulinum toxin type A treatment: hypersensitivity constitution, local infection at the injection site; 3. A history of local botulinum toxin injection within 3 months; 4. Those with conscious disorder who cannot cooperate with treatment; 5. Severe craniocerebral injury with a higher risk of epilepsy; 6. Pregnant and lactating women; 7. Other dystonic diseases, such as myasthenia gravis and Lambert-Eaton syndrome; 8. Those with other acute and chronic diseases, mental diseases, etc. are not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The modified Ashworth scale (MAS) score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fugl-Meyer Assessment Scale (FMA);VisualAnalogue Scale (VAS) score;Modified Barthel index (MBI) score;Berg Balance Scale (BBS) score; | — |
Countries
China
Contacts
Public ContactXu Aihua
First Affiliated Hospital of China Medical University
Outcome results
None listed